Pending Policies - Medicine


Use of Optical Coherence Tomography (OCT) in the Diagnosis and Treatment of Auditory System Conditions

Number:MED201.046

Effective Date:11-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

The use of optical coherence tomography (i.e., PhotoniCare ClearView imaging device) in the diagnosis and treatment of auditory system conditions is considered experimental, investigational and/or unproven.

Description:

Optical coherence tomography (OCT) is a noninvasive diagnostic imaging technique that is used in multiple clinical applications. Historically, OCT applications of the head and neck have primarily focused on characterizing cancer and diseases of the larynx. The expanded use of OCT is being evaluated in patients with otitis media (OM). (1)

Otitis media (OM) is a common, prevalent diagnosis in infants, especially those 6-18 months old. The main cause of OM is middle ear infections caused by bacteria and/or viruses and cannot be visualized with current technology. Typically, the otoscope (the gold standard) is used to assess the condition of the tympanic membrane (TM) surface. The device has several limitations to include it can only visualize the TM surface and the presence of effusion behind the TM when it is transclucent. This subjective observation can be challenging since no quantitative depth-resolved imaging technology exists for imaging the middle ear and assessing the characteristics of any effusion that might be present. These limitations often result in an incorrect diagnosis, which may subsequently affect treatment and patient outcomes. To address these limitations of standard otoscopy, OCT for non-invasive assessment and quantification of the microstructure of the TM and middle ear was employed. (1)

OCT is a diagnostic imaging modality that combines low coherence light with interferometry to produce high-resolution cross-sectional images of living tissues. (2) OCT generates cross-sectional images by using the time delay and intensity of light reflected from the internal tissue structure. OCT has a higher resolution than ultrasound but more shallow penetration of tissue. Tissue resolution of up to 5-10 µm has been achieved, which is approximately 10 times greater than ultrasound. However, the technique is limited by its inability to penetrate more than several millimeters (mm) in depth. (3)

Regulatory Status

The ClearView imaging device (PhotoniCare, Champaign, IL.) is designed to look and handle like a standard otoscope and allows direct visualization of key features in the middle ear, like effusions (fluid) and biofilms (linked to tube surgery). To date, ClearView is the only technology that can see into the middle ear. The device is comprised of 2 optical components: OCT scanning ability and a surface video of the eardrum surface. Per the company’s website (http://photonicareinc.com), the U.S. Food and Drug Administration (FDA) 510(k) is pending. (4)

Rationale:

This policy was created in 2017 based on literature searches of the MEDLINE database through October 31, 2017. Following is a summary of the key literature to date.

In 2008, Djalilian et al. (2) used optical coherence tomography (OCT) to image the tympanic membrane (TM) microstructure in the office setting. In this prospective clinical trial, the normal and diseased TM in 10 adult subjects were studied. Each subject underwent direct microscopic examination before OCT imaging to provide visual coregistration of associated subsites including the anulus fibrosus, pars tensa, pars flaccida, and umbo. The probe from the imaging system (1,310-nm central wavelength, 15-microm coherence length, Niris; Imalux, Cleveland, OH, USA) was introduced into the ear canal to obtain lateral cross-sectional images. Systematic imaging of the TM was performed with characterization of the epithelial and collagenous layers. The overall TM thickness was also demonstrated and quantified. The study concluded that the ability to noninvasively study middle ear microstructures in vivo is essential in the treatment of diseases of the ear. The authors indicated that OCT may provide the physician with the ability to image pathology such as cholesteatoma, dimeric TMs, and chronic otitis media (OM), gauge the response to pharmacological therapy, and monitor postsurgical changes after tympanoplasty and other procedures.

In 2014, Burkhardt and colleagues (5) believed high-speed doppler OCT had the potential to describe the oscillatory behavior of the TM surface in a phase-sensitive manner and also the ability to acquire a three-dimensional (3D) image of the underlying structure. With repeated sound stimuli from 0.4 kHz to 6.4 kHz, the whole TM can be set in vibration and the spatially resolved frequency response functions (FRFs) of the TM can be recorded. Typical points, such as the umbo or the manubrium of malleus, can be studied separately as well as the TM surface with all stationary and wave-like vibrations. Thus, OCT can be a promising technique to distinguish between normal and pathological TMs and support the differentiation between ossicular and TM diseases.

In 2015, Guder et al. (6) conducted a small prospective study (n=11) in which a microscope-based OCT device was used to assess the microanatomy of TM patients with chronic myringitis. OCT measurements of the TM were performed on 11 patients with myringitis with a microscope-based spectral domain OCT system. The in vivo findings were compared with those findings of a control group consisting of 36 patients with retraction pockets or atrophic TMs (n=13), myringosclerosis (n=12) and perforations (n=11). In active chronic myringitis, the thickness of the TM is increased compared to healthy membranes and to other pathological conditions of the TM. Consistent changes of the microanatomy of the TM were found in chronic myringitis with OCT. Serial OCT measurements revealed no biofilm suspicious findings in all patients with active chronic myringitis. The authors concluded that intraoperative and in vivo OCT measurements may help to detect microanatomical changes of the TM in chronic myringitis and in other conditions of the TM.

In 2015, Hubler et al. (7) developed an OCT system for high-resolution, depth-resolved, cross-sectional imaging of the TM and middle ear and for the quantitative assessment of in vivo TM thickness including the presence or absence of a middle ear biofilm. A novel algorithm was developed and demonstrated for automatic, real-time, and accurate measurement of TM thickness to aid in the diagnosis and monitoring of OM as well as other middle ear conditions. The segmentation algorithm applies a Hough transform to the OCT image data to determine the boundaries of the TM to calculate thickness. The use of OCT and this segmentation algorithm was demonstrated first on layered phantoms and then during real-time acquisition of in vivo OCT from humans. For the layered phantoms, measured thicknesses varied by approximately 5 µm over time in the presence of large axial and rotational motion. In vivo data also demonstrated differences in thicknesses both spatially on a single TM, and across normal, acute, and chronic OM cases. Real-time segmentation and thickness measurements of image data from both healthy subjects and those with acute and chronic OM demonstrate the use of OCT and this algorithm as a robust, quantitative, and accurate method for use during real-time in vivo human imaging.

In 2017, Park et al. (8) believed that conventional otoscopes and oto-endoscopes, which are used to examine the TM, do not provide tomographic information. OCT non-invasively reveals the depth-resolved internal microstructure of the TM with very high spatial resolution. We designed this study to examine the TMs with middle ear diseases using a handheld otoscope employing 860 nm spectral domain OCT, combined with video camera and to demonstrate the clinical applicability of this system. A total of 120 patients with otologic symptoms were enrolled. TM images were obtained using the handheld OCT-based otoscope (860 nm central wave length, 15 μm axial resolution, 15 μm lateral resolution, and 7 mm scanning range using relay lens). Both OCT and oto-endoscope images were compared according to the clinical characteristics such as perforation, retraction, and postoperative healing process. The objective grade about the thickness of perforation margins and the accurate information about the extent of TM retraction that was not distinguishable by oto-endoscopic exam could be identified using this system. The postoperative healing process of TMs could be also followed using the OCT device. These analyses from the surgeon-oriented perspective suggest another useful application of the handheld OCT device.

UpToDate

In 2017, UpToDate (9) evaluated all published literature related to acute otitis media in adults and note that examination with a handheld otoscope is the standard method of diagnosis of acute OM. The addition of pneumatoscopy also allows evaluation of TM motion and is highly recommended for diagnosis. Otomicroscopy, available in otorhinology specialty practices, allows even greater definition of the TM. When mastoiditis is suspected, a computerized tomography (CT) scan should always be performed. If there is a concern for an intracranial process (i.e., sigmoid sinus thrombosis, intracranial abscess), then a magnetic resonance imaging (MRI) scan should also be considered.

In 2017, UpToDate (10) accessed the published literature related to the diagnosis of acute OM in the pediatric population. UpToDate noted that the diagnosis of acute OM is facilitated by the systematic assessment of the TM using a pneumatic otoscope and stringent diagnostic criteria to distinguish acute OM from OM with effusion. Otoscopy should be performed using appropriate tools and an adequate light source. Pneumatic otoscopy skills, including accurate interpretation of findings, can be improved through training. A pneumatic otoscope with a round head is preferred because it has the best seal. The nipple on the metal head is the site of attachment for the insufflator bulb, which is used to assess mobility of the TM.

Both UpToDate publications (noted above) do not mention the use of OCT for the diagnosis and treatment of auditory system conditions.

Professional Guidelines and Position Statements

In 2013, The American Academy of Pediatrics (AAP) published guidelines on the diagnosis and management of OM. (11) This guideline was also endorsed by the American Academy of Family Physicians (AAFP) and focuses on children 6 months through 12 years of age. These guidelines affirm pneumatic otoscope as the standard tool used in diagnosing OM. The pneumatic otoscope permits assessment of the contour of the TM (normal, retracted, full, bulging), its color (gray, yellow, pink, amber, white, red, blue), its translucency (translucent, semiopaque, opaque), and its mobility (normal, increased, decreased, absent). Specific landmarks can be visualized which include the short process and the manubrium of the malleus and the pars flaccida, located superiorly. These landmarks are easily observed and help to identify the position of the TM. The pneumatic otoscope should have a light source of sufficient brightness and an air-tight seal that permits application of positive and negative pressure.

In August 2017, the AAP published guidelines (12) for acute OM which note “The presence of middle ear effusion should be determined through the combined use of otoscopy, pneumatic otoscopy, and tympanometry when necessary”.

Neither the 2013 or the 2017 AAP guidelines mention OCT as a treatment modality for the diagnosis and/or treatment of OM.

Summary of Evidence

Currently, there is inadequate published peer reviewed literature to permit scientific conclusions regarding the safety and efficacy on the use of OCT for the diagnosis and treatment of auditory system conditions. Additional well-conducted long term randomized controlled trials with sufficiently large sample sizes are needed to determine the impact on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0485T, 0486T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Cho N, Lee S, Jung W, et al. Optical coherence tomography for the diagnosis and evaluation of human otitis media. J Korean Med Sci. 2015 Mar; 30(3): 328-335. PMID 4330490

2. Djalilian HR, Ridgway J, Tam M, et al.Imaging the human tympanic membrane using optical coherencetomography in vivo. Otol Neurotol. 2008 Dec; 29(8):1091-4. PMID 18957904

3. Prati F, Regar E, Mintz GS, et al. Expert review document on methodology, terminology, and clinical applications of optical coherence tomography: physical principles, methodology of image acquisition, and clinical application for assessment of coronary arteries and atherosclerosis. Eur Heart J. 2010; 31(4):401-15. PMID 19892716

4. PhotoniCare – ClearView imaging device (2017). Available at <http://photonicareinc.com> (accessed-2017 November 14).

5. Burkhardt A, Kirsten L, Bornitz M, et al. Investigation of the human tympanic membrane oscillation ex vivo by Doppler optical coherence tomography. J Biophotonics. 2014 Jun;7(6):434-41. PMID:23225692

6. Guder E, Lankenau E, Fleischhauer F, et al. Microanatomy of the tympanic membrane in chronic myringitis obtained with optical coherence tomography. Eur Arch Otorhinolaryngol. 2015 Nov; 272(11):3217-23. PMID 25384576

7. Hubler Z, Shemonski ND, Shelton RL, et al. Real-time automated thickness measurement of the in vivo human tympanic membrane using optical coherence tomography. Quant Imaging Med Surg. 2015 Feb; 5(1):69-77. PMID 25694956

8. Park K, Cho NH, Jeon M, et al. Optical assessment of the in vivo tympanic membrane status using a handheld optical coherence tomography-based otoscope. Acta Otolaryngol. 2017 Nov; 10:1-8. PMID 29125012

9. Limb C, Lustig L, Klein J, et al. Acute otitis media in adults. 2017. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Available at <http://www.uptodate.com> (accessed-2017 November 29).

10. Wald E. Acute otitis media in children: Diagnosis. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Available at <http://www.uptodate.com> (accessed-2017 November 29).

11. Lieberthal A, Carroll A, Chonmaitree T, et al. American Academy of Pediatrics. Clinical practice guideline: The Diagnosis and Management of Acute Otitis Media (2017). Available at <http://pediatrics.aappublications.org> (accessed-2017 November 29).

12. Donaldson JD. Acute otitis media guidelines: Summary guidelines. (2017). Available at <https://emedicine.medscape.com> (accessed-2017 November 28).

Policy History:

Date Reason
11/1/2018 Reviewed. No changes.
1/1/2018 New medical document. The use of optical coherence tomography (i.e., PhotoniCare ClearView imaging device) in the diagnosis and treatment of auditory system conditions is considered experimental, investigational and/or unproven.

Archived Document(s):

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